New FDA Approval for VENCLEXTA™

On April 11, 2016, VENCLEXTA™ (venetoclax) was approved by the US Food and Drug Administration (FDA). 

Genentech BioOncology Access Solutions offers a full range of access and reimbursement support for your patients and practice after VENCLEXTA is prescribed. Our Specialists can help you conduct benefits investigations on behalf of your patients so you can understand what is covered before the start of treatment. A list of specialty distributors and specialty pharmacies authorized to distribute VENCLEXTA can be found at

Click Here for the complete Prescribing Information.

Click Here for sample coding and billing information. 

New FDA Approval for GAZYVA®

GAZYVA® obinutuzumab) is NOW FDA APPROVED for use in combination with bendamustine followed by GAZYVA monotherapy for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen.

Click Here for the Prescribing Information.

Click Here for coding and other information. 

You are encouraged to report side effects to Genentech and the FDA. You may contact Genentech by calling 1-888-835-2555. You may contact the FDA by visiting or calling 1-800-FDA-1088.


The Centers for Medicare & Medicaid Services (CMS) assigned a HCPCS code for BLINCYTO® which became effective on January 1, 2016.  



BLINCYTO Long Descriptor

Effective Date


Injection, blinatumomab, 1mcg


Source: Centers for Medicare and Medicaid Services Alpha-Numeric HCPCS File

Source Link: CMS 2016 Alpha-Numeric HCPCS File


BLINCYTO was approved by the US Food and Drug Administration on December 3, 2014, for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).  This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials.

Journal of Clinical Oncology Publishes Prospective Outcomes Results from Large International Trial Using Oncotype DX(R)

Press Release from Genomic Health
New Publication of Results from 'PlanB' Study Reinforces Unique Value of Oncotype DX, the Only Multi-gene Breast Cancer Test with Prospective Outcomes Evidence in More Than 50,000 Patients
Five-year Results Accepted for Oral Presentation at European Breast Cancer Conference, Included in Official Congress Press Program

REDWOOD CITY, Calif., March 1, 2016 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced that the Journal of Clinical Oncology published clinical outcomes results from PlanB, one of Europe's largest adjuvant studies that utilized the Oncotype DX® breast cancer test to assign treatment. Led by the Women's Healthcare Study Group (WSG) in Germany, results from the PlanB study showed that women with Oncotype DX Recurrence Score® results of 11 or less had excellent outcomes with 98 percent disease-free survival rates at three years, despite having high-risk disease by traditional parameters. This finding is consistent with conclusions of the Trial Assigning IndividuaLized Options for Treatment (Rx), or TAILORx, recently published in The New England Journal of Medicine, adding to the unprecedented body of evidence demonstrating that Oncotype DX accurately predicts outcomes, including breast cancer recurrence and survival, in data collected from more than 50,000 patients.

"The compelling suite of new global prospective outcomes data generated in the last six months proves that tens of thousands of patients worldwide can forgo chemotherapy and its harmful side effects based on a low Recurrence Score," said Steven Shak, M.D., chief scientific officer, Genomic Health. "Not only do these collective results support our prior validation work and all of the guidelines worldwide that include Oncotype DX to select patients for chemotherapy treatment, they also provide physicians with the highest level of evidence to support using the test as standard of care."

This large study, conducted in 93 centers across Germany, enrolled more than 3,100 patients with high-risk, estrogen-receptor positive, HER2-negative early-stage breast cancer, including those with node-positive disease who were considered candidates for chemotherapy by traditional parameters. Oncotype DX Recurrence Score results were used to identify patients who would be spared adjuvant chemotherapy despite being considered as having high clinical risk by traditional parameters. Participants with Recurrence Score results of 12 or higher were randomized to different chemotherapy regimens, and patients with Recurrence Score results of 11 or less were treated with hormonal therapy alone.

The study showed that women with Recurrence Score results of 11 or less had excellent outcomes at three years despite having high-risk disease by traditional parameters, such as nodal status. The results indicate that chemotherapy can safely be spared in patients with high clinical risk of recurrence - including node-positive disease - if the Recurrence Score result is 11 or less.

"Our study results show that a low Recurrence Score result identifies patients who can be safely spared chemotherapy without compromising outcomes. These results confirm previous retrospective studies as well as the prospective TAILORx trial," said Prof. Nadia Harbeck, WSG Scientific Director and Head of the breast cancer unit at University of Munich, Germany.

Findings from the PlanB study also suggest there may be overtreatment in a substantial subset of patients who have Recurrence Score results between 12 and 25, as patients in this range also had excellent outcomes with disease-free survival of 98 percent at three years. These findings add to a recent study from Clalit Health Services, the largest Health Maintenance Organization in Israel, that showed that women with Recurrence Score results of less than 18 who were largely treated with hormonal therapy alone had excellent outcomes with less than a one percent chance of distant recurrence or breast cancer-specific mortality at five years.

"Patients should only get chemotherapy with all its side effects if they are going to benefit substantially. Gene expression tests often play an important role in making this decision," said Renate Haidinger, president of the German Breast Cancer Association, the leading national patient advocacy organization in Germany. "Based on the latest study results, we hope that patients can get broad access to this test."

Five-year results from PlanB will be highlighted in the official European Breast Cancer Conference (EBCC-10) press program on Thursday, March 10, followed by the oral presentation on Friday, March 11, at a plenary session.


FDA Expands Use of IBRANCE®

On February 19, 2016, the FDA approved a new indication expanding the use of IBRANCE® (palbociclib). The new indication in combination with fulvestrant is supported by the results of PALOMA-3, a Phase 3 trial.1


IBRANCE is indicated for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in combination with:


• letrozole as initial endocrine-based therapy in postmenopausal women, or

• fulvestrant in women with disease progression following endocrine therapy


The indication in combination with letrozole is approved under accelerated approval

based on progression-free survival (PFS). Continued approval for this indication may

be contingent upon verification and description of clinical benefit in a confirmatory trial.


This first-in-class therapy is now approved for use in a broader range of women. Now, in addition to being a first-line treatment option in combination with letrozole, IBRANCE can also be used in combination with fulvestrant in patients with disease progression on or after prior endocrine therapy in the adjuvant or metastatic setting.

Click Here to read the announcement from Pfizer.

U.S. FDA Approves IMBRUVICA® (ibrutinib) for First-line Treatment of Chronic Lymphocytic Leukemia

The U.S. Food and Drug Administration (FDA) has approved IMBRUVICA® (ibrutinib) capsules for treatment-naïve patients with chronic lymphocytic leukemia (CLL).[i] The approval is based on data from the Phase 3 RESONATE-2 (PCYC-1115) study, the first head-to-head clinical trial comparing IMBRUVICA to a chemotherapy agent. Results showed IMBRUVICA significantly extended progression-free survival (PFS; the primary endpoint) and increased overall response rate (ORR; a key secondary endpoint) compared to chlorambucil in previously untreated patients with CLL age 65 or older. IMBRUVICA is now approved for use in all lines of CLL therapy, considerably expanding the number of patients who may benefit from this treatment. This broadens the indication beyond the initial CLL approval in February 2014 for the treatment of patients with CLL who have received at least one prior therapy and in July 2014 for CLL patients with del 17p,1 a genetic mutation typically associated with poor treatment outcomes.[ii] IMBRUVICA is jointly developed and commercialized by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company.

[i] IMBRUVICA Prescribing Information, March 2016.

2 NCCN Clinical Practice Guidelines in Oncology. Non-Hodgkin’s Lymphomas. Version 2.2016. Available from: Accessed March 2016.

Click Here to read the entire Press Release from Janssen. 

New FDA Approval for Merck'ssingle-dose EMEND® (fosaprepitant dimeglumine)

On Feb. 4, 2016 Merck announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for single-dose EMEND® (fosaprepitant dimeglumine) for injection, Merck’s substance P/neurokinin-1 (NK1) receptor antagonist, in combination with other antiemetic medicines, for the prevention of delayed nausea and vomiting in adults receiving initial and repeat courses of moderately emetogenic chemotherapy (MEC). 

Click Here to read the Press Release from Merck.

Click Here to read Merck's Announcement Letter. 

FDA Expands Use of Bristol-Myers Squibb's Opdivo + Yervoy Regimen

Opdivo + Yervoy Regimen now indicated for unresectable or metastatic melanoma patients, regardless of BRAF mutational status, based on accelerated approval.

Click Here to read the press release from Bristol-Myers Squibb.